14 ms·
Since no one has done it yet, I'll ask the obvious question about the FDA: how many people die or need a liver transplant each year because the FDA is being un
by nkurz 4y ago
Since no one has done it yet, I'll ask the obvious question about the FDA: how many people die or need a liver transplant each year because the FDA is being unreasonable here?
Here's some quotes from the article:
Approximately 40% of people who ingest the deadly Amanita mushrooms die or require a liver transplant, according to Dr. Pierre Gholam, the liver specialist at University Hospitals who treated Hickman.
...
They immediately began preparing an application to the FDA for the emergency use of an investigational antidote – that if administered within 72 hours of ingestion can prevent liver damage and death in almost every patient who receives it.
The drug, called Silibinin, is derived from the milk thistle plant and given intravenously. It has been available in Europe for over 30 years, but here in the United States it has yet to be approved by the FDA, so it is not stocked in hospitals or pharmacies.
The result is that in order to obtain it for patients, an emergency use application must be submitted to the FDA for every patient who needs it, after which it is flown in by courier directly from the FDA laboratory in Philadelphia.
“This literally takes an army of people working after hours,” said Gholam. “There are tireless, really unsung heroes at the UH research office who make this happen for every patient – they have to do this over and over and over.” Forty-seven times in the last 10 years to be exact.
The biggest enemy in this process, says Gholam, is time. If the drug is administered after the 72-hour window closes, the chances of a full recovery drop dramatically.
Making licensed physicians jump through these hoops while risking their patients lives should be a criminal offense. Yes, it's great that this particular patient survived, but there needs to be a better cost benefit analysis for drug approval. Almost certainly, there are patients who have suffered permanent damage or death because of the difficulty of obtaining this drug. What benefit is there to making this drug so hard to get? How many people miss the time window because of these requirements? How safe does a drug need to be if result of not getting it is a 40% chance of death or a liver transplant?
- colechristensen 4y agoCouldn’t the patient just take a bunch of the milk thistle supplements available at most pharmacies?
- EdwardDiego 4y agoGiven the link between milk thistle usage over time and thyroid disorder, I'm amazed it's available.
- ceejayoz 4y ago"derived from the milk thistle plant" likely involves more than just "eat some powered plant"; Wikipedia seems to indicate it involves more purification steps than the supplement form of things.
- colechristensen 4y agoThere’s a difference between purifying and using something as a basis for synthesis. The question is, why not the plant itself? (Dried and powdered in a readily available pill)
- adrr 4y agoDose is probably really low if you just used dried milk thistle and you need to refining and purify it to take via an IV. Same goes with acetylcysteine for Tylenol a overdose, you need to get it via an IV and you can’t just take the over the counter supplement.
- 1letterunixname 4y agoAlso, every household that has Tylenol should have, and co-administer, N-acetyl-cysteine (NAC) because it's hepatoprotective. The stinky sulfurous supplement that the FDA partially banned.
- EdwardDiego 4y agoSilychristin[0] and mycotoxins[1]? [0]: https://academic.oup.com/endo/article/157/4/1694/2422745?login=false https://academic.oup.com/endo/article/157/4/1694/2422745?log... [1]: https://pubs.acs.org/doi/10.1021/acs.jafc.5b02105 https://pubs.acs.org/doi/10.1021/acs.jafc.5b02105
- 4y ago
- bombcar 4y agoWith a 72 hour window it sounds simpler to bundle the patient in a plane to Europe.
- thaumasiotes 4y agoYou also have the option of flying to Europe, getting the drug, and flying back with it to give to the patient.
- mattigames 4y agoWith the ridiculous prices of health care in America it's likely also cheaper too.
- 1letterunixname 4y agoA bicycle accident bill can be over 100k USD without any surgery or being admitted overnight. Having a stroke can be 500-600k which might cause another upon seeing the bill.
- whatshisface 4y agoPeople do not pay $500k bills for strokes, that's not possible.
- LambdaComplex 4y ago"Do people pay $500k hospital bills?" and "Do people receive $500k hospital bills?" are two different questions.
- bombcar 4y agoIn fact it’s to the insurance companies benefit to have the original bill be as insanely high as possible, before negotiating a “discount” and paying half - makes them look better and scares people from not having insurance.
- coryrc 4y ago[flagged]
- rblatz 4y agoMaybe this is the only way to reliably make available a drug that is used nationwide on average less than 5 times a year? Most hospitals wouldn’t stock a drug that they’d likely never use. By keeping stock centralized at the FDA they can keep enough on hand and rubber stamp the exception.
- inkblotuniverse 4y agoKeeping emergency stocks of rarely-used drugs is fine, but you don't have to make it illegal for anyone else to stock that drug to accomplish that.
- sacrosancty 4y agoIsn't the whole idea of requiring FDA approval to protect patients from harmful or ineffective drugs? If having and administering whatever drugs you wanted was legal, then how can anyone be protected? No doubt, they're still getting around to approving it but are just too slow and have this exception process precisely to save people's lives until they get it done properly.
- s1artibartfast 4y agoManufacturers, ask the FDA for approval. The FDA doesn't just go around approving drugs. surprisingly, I guess this is a common misunderstanding.
- Aloha 4y ago"Gholam says that the process of FDA approval for Silibinin is slow, primarily because it only works for amatoxin poisoning, from the Amanita mushroom species. Those poisonings are rare – so gathering enough data to satisfy the safety and efficacy requirements of the FDA takes time. And there is little financial incentive by the company that owns the drug to invest in its research and development." Incidentally, these protections exist because of several breakdowns in drug safety in the past, notably Elixir sulfanilamide and Thalidomide. I'm not suggesting that there should be no improvements, I think there should be a conditional use waiver program that allows these drugs to be in the field. But suggesting that it should be criminal that it's not is over the top moralizing and provocation of outrage for little return. Also, there are good reasons why this drug is restricted access too - https://en.wikipedia.org/wiki/Silibinin https://en.wikipedia.org/wiki/Silibinin
- dekhn 4y agoThalidomide is a very useful drug that is still prescribed today.
- salawat 4y ago>Thalidomide is a very useful drug that is still prescribed today. With a metric shit ton of caveats, that were outright denied until the public raised an unholy fuss with regulators to get it clamped down on in light of the severity of birth defects/reproductive complications it produces.
- derefr 4y agoMy question is: why does the FDA need to (get domestic pharma companies to) conduct its own studies here? If the drug has been used in Europe for 30 years, presumably there are 30 years of evidence in European clinical practice that can be used as evidence. Maybe even existing meta-analyses of said evidence in European medical journals. Why isn't that sufficient?
- Aeolos 4y agoThe FDA does not accept any studies conducted overseas as clinical evidence. They request studies to contain at least 50% US citizens and be analyzed by US certified physicians. Now whether that leads to better outcomes or is just a protectionist measure for the local industry is anyone’s guess. A bit of both, I would imagine.
- rex_lupi 4y ago> despite its several beneficial effects on the liver, silibinin and all the other compounds found in silymarin, especially silychristin seem to act as potent disruptors of the thyroid system by blocking the MCT8 transporter. The long term intake of silymarin can lead to some form of thyroid disease and if taken during pregnancy, silymarin can cause the development of the Allan–Herndon–Dudley syndrome. Although this information is not being taken into consideration by all regulatory bodies, several studies now consider silymarin and especially silychristin to be important inhibitors of the MCT8 transporter and a potential disruptor of the thyroid hormone functions. (From Wikipedia) I guess emergency use would still be okay?
- deleted 4y ago[deleted]
- scotty79 4y agoThe funny thing is that 100 mg of Silybi mariani fructus extactum siccum is OTC in Poland used for liver problems that people might have after ingesting a heavy meal. And it's been for decades without any safety issues. Granted that in cases of mushroom poisoning it's given only in hospital setting probably through IV, probably in much higher doses. But those people would die without it. Any reasonable safety profile of this drug is better than safety profile of untreated deathcap poisoning.
- londons_explore 4y agoSafety certifications tend to be blanket 'this thing is safe to treat this disease' things. Whereas they should be 'in the last 10 years, 100 people were treated with this drug and 27% survived. 71 were not treated with the drug and 1% survived. You use your professional judgement to decide if it is suitable for your patient'. The FDA shouldn't be doing blanket approvals or bans. They should be making the information available for medical professionals to make the decision themselves.
- jmcgough 4y agoFDA approvals aren't based on absolute safety, they're based on a risk/reward analysis.
- refurb 4y agoI’m guessing because evidence is limited it helps much? https://emj.bmj.com/content/33/1/76.2 https://emj.bmj.com/content/33/1/76.2
- 411111111111111 4y ago> This literally takes an army of people working after hours,” said Gholam. “There are tireless, really unsung heroes at the UH research office who make this happen for every patient – they have to do this over and over and over.” Forty-seven times in the last 10 years to be exact. Ohh, the poor guys have to hand in 4.7 forms per year to get access to an unapproved medicine they need. I would've thought it was satire, but it seems you're serious? Amazing.
- smeej 4y agoWhy is something that's been approved in Europe for 30 years still waiting for FDA approval in the first place? If they issue the medication immediately after the form is submitted, without further inquiry or scrutiny (which is actually good in the case of something this urgent), why are they even bothering keeping it under such lock and key anyway? That's what would sound like satire to anyone without an unflinching faith in the importance of a nanny state.
- s1artibartfast 4y agoThe point is to track and monitor its use if it is not approved. The inquiry and scrutiny exists. Im not sure why you assume it doesnt. Do all of the patients die from the drug? Are doctors administer it as a new fad for the common cold, ect?
- smeej 4y agoI assume it doesn't because U.S.-government-level "inquiry and scrutiny" takes at least an order of magnitude longer than 72 hours. If they're getting this done in time for it to be useful, it's just being rubber-stamped. Do you sincerely think the EU would keep a drug available for common use if everyone who took it died? If not, drop the red herring and try to have a halfway serious discussion.
- 411111111111111 4y agoI mean the argument was that that "they have to keep filling out these forms, causing lots of overtime", that was the argument I pointed out to be unreasonably dumb considering it's less then 5 times per year. So... The one that's doing that is pretty much you. None of us can argue about wherever the drug should be approved by now, as we don't know why it isn't yet. You'd have to first get a statement from the agency before that discussion can take place
- quickthrower2 4y agoWithout wanting to be callous, 47 people in 10 years, then look at common cold, flu, covid etc. It should be very low on the priority list if you optimise for saving lives.
- junofan 4y agoThe FDA’s mandate is to evaluate marketing claims, not optimize for saving lives.
- s1artibartfast 4y agoThis is correct, The FDA does not seek out and approve drugs. It reviews applications for approval.
- fredgrott 4y agoyou should note that Trump had no problem getting FDA approval for his own COVID treatments. I guess FDA only understands the urgency only if you have money and power.
- pigbearpig 4y agoIt's not criminal to be cautious about approving drugs. Remember the people affected have purposely eaten a wild mushroom -- they risked their own lives first.
- pzone 4y agoIt should be criminal given the immense harm that it causes. The FDA’s single minded obsession with liability holds back medical advances that could save lives.
- yonaguska 4y agoExcept in the case of COVID shots. Liability was tossed to the wind, partially as a result of political pressure.
- chiefalchemist 4y agoNot necessarily. Would a child know the risks? Making a one-off decision that ends up with a bad outcome is no reason to punish someone further. "Oh sorry. It was you that ran the red light. The other car that hit you is not at fault. We can't treat you. It was your decision." Really?
- pfisherman 4y agoFDA will consider real world data and real world evidence in regulatory decision making. If this has been in use in the EU for 30 years, then where is the data? Robert Califf (FDA commissioner) has a funny saying, “In God we trust. All others must bring data.”
- oldgradstudent 4y ago> how many people die or need a liver transplant each year because the FDA is being unreasonable here? That would depend on whether it is effective. Is it?
- shrthnd 4y agoMilk thistle...
- justshowpost 4y agoWell, given they were injecting untested and unproven SARS-CoV-2 "vaccine" which wasn't even a vaccine till they changed the definition, they could do a traditional medicine plant despite the mild toxicity and the absence of other clinical evidence... But why FDA is to blame? Just get it from nearby euro-drugstore and do your unlicensed fix.